Cost-effectiveness and cost-utility of at-home infrared temperature monitoring in reducing the incidence of foot ulcer recurrence in patients with diabetes.

Completed

Conditions: Diabetic foot
diabetic neuropathy
10012653

Registration Number: NL-OMON44744

Lead Sponsor: Academisch Medisch Centrum

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Completed

Sex: Not specified

Target Recruitment: 304

Inclusion Criteria

1. Diabetes mellitus;
2. Age 18 or above;
3. Peripheral neuropathy;
4. Recent history of a foot ulcer or foot amputation, i.e. an ulcer has been present for at least 2 weeks and has healed within four years before randomization, or a diagnosis of midfoot or forefoot Charcot neuro-osteoarthropathy;
5. Ability to provide informed consent;
6. Ambulatory status (i.e. not permanently wheel-chair bound).
7. The patient is treated by a podiatrist or is willing to undergo treatment by a podiatrist from the study.

Exclusion Criteria

1. Active foot ulceration or open amputation sites.
2. Active Charcot neuro-osteo arthropathy.
3. Active foot infection, based on criteria of the PEDIS classification.
4. Amputation proximal to the Chopart joint in both feet.
5. Severe illness that would make 18-months survival unlikely, based on the clinical judgment by the physician
6. Concomitant severe physical or mental conditions that limit the ability to follow instructions for the study, based on the clinical judgment by the physician. This includes the inability to perform temperature measurements, without having a caretaker who can perform the temperature measurements.
7. Current use of home-monitoring of foot temperature.
8. Critical limb ischemia, based on criteria of the PEDIS classification

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>- Costs per patient without a foot ulcer and per quality adjusted life year.<br /><br>- The proportion of patients with a foot ulcer recurrence during 18-month<br /><br>follow-up.</p><br>

Secondary Outcome Measures

Name	Time	Method
<p>- Costs of advanced therapy and ulcer treatment.<br /><br>- Adherence to at-home foot temperature monitoring.<br /><br>- Health-related quality of life. </p><br>